PALFIQUE LIGHT BONDING AGENT— 510(k) K897009

Name: FDA 510(k) clearance K897009
Creator: U.S. Food and Drug Administration
Published: 1990-05-15

Substantially Equivalent

Tokuyama America, Inc.

FDA 510(k) clearance K897009 for PALFIQUE LIGHT BONDING AGENT, Substantially Equivalent on 1990-05-15. Applicant: Tokuyama America, Inc.. Device class: 2.

Clearance details

Applicant: Tokuyama America, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1989-12-13
Decision date: 1990-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.